TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER).
Total parenteral nutrition (TPN) solution providing essential amino acids, electrolytes, and dextrose. Dextrose supplies calories to spare protein catabolism; amino acids support protein synthesis; electrolytes maintain acid-base and fluid balance.
| Metabolism | Dextrose is metabolized via glycolysis and the citric acid cycle to carbon dioxide and water, with insulin-mediated uptake. Amino acids are metabolized via deamination and transamination, with nitrogen excreted as urea. Electrolytes are excreted or retained as needed. |
| Excretion | Amino acids and dextrose are metabolized; excess nitrogen is excreted as urea via renal route (approximately 90% of nitrogen output). Electrolytes are excreted renally. Biliary/fecal elimination is minimal (<5%). |
| Half-life | Not applicable as a single entity; components have various half-lives. Glucose has a plasma half-life of approximately 1.5-2 hours. Amino acids have variable half-lives (minutes to hours). Clinical context: continuous infusion maintains steady state. |
| Protein binding | Amino acids: minimal binding (<20%) to albumin. Dextrose: not bound. Electrolytes: variable (calcium ~45% bound to albumin; magnesium ~30% bound; others minimally bound). |
| Volume of Distribution | Amino acids: Vd ~0.3-0.6 L/kg, reflecting distribution to total body water. Dextrose: Vd ~0.2 L/kg (extracellular fluid). Electrolytes: Vd varies (sodium ~0.5 L/kg, potassium ~0.6 L/kg, calcium ~0.5 L/kg, magnesium ~0.6 L/kg). |
| Bioavailability | Intravenous: 100% bioavailable. |
| Onset of Action | Intravenous: immediate onset for hemodynamic effects (dextrose) and amino acid availability; clinical effects (metabolic support) begin within minutes. |
| Duration of Action | Duration depends on infusion rate; effects persist during infusion. After discontinuation, metabolic effects wane over hours. Dextrose effect lasts 2-3 hours post-infusion. |
Intravenous administration of 1.5-2.5 L/day in divided doses, adjusted based on metabolic needs, fluid status, and electrolytes. Typical rate: 100-200 mL/hour via central line.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: reduce volume by 20-50% and monitor electrolytes closely. GFR <15 mL/min: avoid use or use with extreme caution; consider renal replacement therapy. |
| Liver impairment | Child-Pugh Class B: reduce protein load by 25-50% and monitor ammonia. Child-Pugh Class C: avoid use due to risk of hepatic encephalopathy. |
| Pediatric use | Weight-based: 100-150 mL/kg/day for children, adjusted for age and clinical condition. Initiate at 50-75 mL/kg/day and titrate. Use with caution in neonates due to immature renal function. |
| Geriatric use | Elderly patients: use lower initial doses (75-100 mL/hour) and titrate slowly. Monitor fluid overload, electrolyte imbalances, and renal function closely due to decreased physiological reserve. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER).
| Breastfeeding | Excretion into breast milk of components is negligible at clinical doses. Dextrose is normal milk constituent. Amino acids and electrolytes are present in milk and regulated by maternal homeostasis. M/P ratio not established but expected to be low. Compatible with breastfeeding; monitor infant for electrolyte disturbances if maternal levels abnormal. |
| Teratogenic Risk | Travasol 4.25% with electrolytes in dextrose 25% is a parenteral nutrition solution. No teratogenicity studies exist in humans. In animal studies, dextrose and amino acids have not been associated with teratogenic effects at clinical doses. Dextrose may cause fetal hyperinsulinemia and hypoglycemia if maternal hyperglycemia occurs, particularly in third trimester. Electrolytes are transferred across placenta and may affect fetal electrolyte balance if maternal levels are abnormal. Overall risk is low with appropriate maternal monitoring. |
■ FDA Black Box Warning
Not for injection into low-flow or central veins; risk of air embolism if administration set is not properly purged. Fatalities have occurred due to air embolism or thrombosis from central venous catheter placement.
| Serious Effects |
Hypersensitivity to any component; severe electrolyte abnormalities; anuria; severe hepatic failure; hyperglycemic states (e.g., diabetic ketoacidosis) unless appropriately treated; use in neonates with elevated bilirubin due to sulfite content (sulfite-free formulation reduces risk but still contraindicated if sulfite sensitivity).
| Precautions | Risk of hyperglycemia, osmotic diuresis, and hyperosmolar coma; monitor serum glucose, electrolytes, and fluid balance. Central line infection, sepsis, air embolism, thrombosis. Electrolyte imbalances (hyperkalemia, hypercalcemia). Aluminum toxicity in renal impairment. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, glucose, acid-base status, and fluid balance. Fetal surveillance including ultrasound for growth and amniotic fluid volume if prolonged use. Blood glucose monitoring in pregnancy to avoid maternal hyperglycemia. Fetal heart rate monitoring if maternal metabolic abnormalities occur. |
| Fertility Effects | No known effects on fertility from components at recommended doses. Amino acids and dextrose are essential nutrients; electrolyte imbalance could theoretically impact reproductive function but not reported. |